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A Study of Flurbiprofen 8.75 mg Lozenge in Patient With Pharyngitis

Information source: Reckitt Benckiser Inc.
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pharyngitis

Intervention: Placebo (Drug); Flurbiprofen (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Reckitt Benckiser Inc.

Official(s) and/or principal investigator(s):
Timothy J Shea, BS, Study Director, Affiliation: Reckitt Benckiser Inc.

Overall contact:
Timothy J Shea, BS, Phone: 973 404 2883, Email: tim.shea@reckittbenckiser.com

Summary

The purposes of this study is to demonstrate the analgesic efficacy of flurbiprofen 8. 75 mg lozenge compared to its vehicle lozenge and to demonstrate the safety of the flurbiprofen lozenge throughout the course of treating sore throat due to acute pharyngitis.

Clinical Details

Official title: A Randomized, Double-Blind, Placebo-Controlled Multiple-Dose Study to Determine the Efficacy, Onset, and Duration of Action of Flurbiprofen 8.75 mg Lozenge Compared to Its Vehicle Control Lozenge in Patients With Painful Pharyngitis

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: The primary Outcome Measure in this trial will be efficacy for Sore Throat Pain during the first 24 hours.

Secondary outcome: The Secondary Outcome Measure in this trial will be efficacy for Sore Throat Pain during the first 2 hours.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. The patient has a complaint of sore throat.

2. If the patient is a female of childbearing potential, she has been using effective contraception since the last date of menses and is not breast-feeding or lactating.

3. If the patient is a female of childbearing potential, the patient must have a negative urine pregnancy.

4. The patient has provided written informed consent prior to any study-related procedures.

Exclusion Criteria:

1. The patient has a history of an upper gastrointestinal ulcer within the past 60 days, is currently experiencing clinically significant upper gastrointestinal complaints, or is currently taking medication regularly (≥ three times in the previous week).

2. The patient has a history of any hepatic disease or renal dysfunction.

3. The patient has a history of chronic analgesic use (≥ three times per week over the prior four weeks). (Patients on low-dose aspirin therapy may be allowed in the study per investigator's clinical decision.)

Locations and Contacts

Timothy J Shea, BS, Phone: 973 404 2883, Email: tim.shea@reckittbenckiser.com

Bluestone Center for Clinical Research, New York, New York 10010, United States; Recruiting
Turner, Phone: 212-998-9568
Additional Information

Starting date: November 2009
Last updated: January 13, 2010

Page last updated: October 04, 2010

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